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Spectra Safe-Cut® Safety Scalpel
EUDAMEDClass IIa (EU MDR)
Ref S-11SMD-SSH-BCModel S-11SMD-MSS-B , S-10SMD-SSH-GC ,S-11SMD-SSH-BC , S-15SMD-SSH-YC
Identity
- Trade Name
- Spectra Safe-Cut® Safety Scalpel EUDAMED
- Device Name
- Spectra Safe-Cut® Safety Scalpel EUDAMED
- Model / Reference
- S-11SMD-MSS-B , S-10SMD-SSH-GC ,S-11SMD-SSH-BC , S-15SMD-SSH-YC EUDAMEDS-11SMD-SSH-BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M661Inst2AWT EUDAMED
- Basic UDI-DI
- B-+M661Inst2AWT EUDAMED
- EMDN Code
- V010101 SCALPELS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spectra Safe-Cut® Safety Scalpel by Spectra Medical Devices, LLC — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-+M661Inst2AWT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spectra Medical Devices, LLC
- EUDAMED SRN
- US-MF-000008491
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED ee4e39f3-0f48-42b2-80dc-9c552c1391c9 61 fields · synced Jun 18, 2026